Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Siemens has confirmed that the dbil_2 assigned calibrator values (acv) currently assigned to certain lots may cause on average a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement. due to the proportional bias the differences become greater as the concentration of dbil_2 increases. quality control (qc) material is also affected by this issue. depending on the quality control concentrations and ranges used by the laboratory quality control may not detect this issue.